• Regulatory NewsRegulatory News

    FDA, CDC Preparing Updated Form to Record Vaccination Problems

    The US Centers for Disease Control and Prevention (CDC) and US Food and Drug Administration (FDA) are calling for comments on a new adverse event reporting form for vaccines meant to replace the current paper-based reporting form. Background In a notice published in the Federal Register on 24 November 2014, CDC said it's accepting public input on its proposed Vaccine Adverse Event Reporting System (VAERS) 2.0 form. VAERS is used by FDA and CDC, which co-administer th...
  • Regulatory NewsRegulatory News

    FDA, CDC Put $18M Behind Adverse Event System for Vaccines

    The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have awarded a new, $18 million contract meant to support its existing Vaccine Adverse Event Reporting System (VAERS) over the next five years. The award will go to Virginia-based SRA International, the company announced in a 17 November 2014 press release . SRA has supported FDA's VAERS program since 1999, it said. VAERS is used by FDA to collect and analyze reports of vacci...
  • Regulatory NewsRegulatory News

    With New Rule in Place, FDA Establishes Procedures for Submitting Vaccine Safety Problems

    A new draft guidance document issued this week by the US Food and Drug Administration (FDA) establishes best practices for the submission of safety reports related to the use of vaccines. Background FDA has since 2009 been advocating for a rule which would require all mandatory postmarketing safety reports to be submitted to the agency in electronic form (instead of paper), saying that the change could allow it to better process, review and archive the documents. The r...
  • Regulatory NewsRegulatory News

    FDA Launching Pilot Program to Assess Vaccine Safety Reporting Capabilities

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is launching a pilot program intended to assess its capacity to receive reports of adverse events related to the use of vaccines. At present, CBER—working in tandem with the Centers for Disease Control and Prevention (CDC)—receives vaccine-related adverse events electronically through its Vaccine Adverse Event Reporting System (VAERS), which accepts the International Conferenc...
  • CBER Wants Better Vaccine Safety, Identify Adverse Events

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is announcing its intent to launch a program to ensure the safety of vaccine products manufactured around the globe by enhancing the regulatory capacity of emerging nations. CBER's initiative, dubbed the "Global Regulatory Utilization of Vaccine Safety and Surveillance (GRUVSS) initiative," is in response to what FDA described as a "dramatic increase in the global use of vacci...